New Company Code requires marketing authorisation holders to amend their documents

The new Belgian Company Code, which concerns companies and associations, and which came into force on 1 May 2019, refers to only 4  corporate forms. This will have implications for some authorisations and registrations in the sense that holders thereof are now required to amend their documents.

The private limited liability company (besloten vennootschap met beperkte aansprakelijkheid - bvba or société privée à responsabilité limitée - SPRL) and cooperative limited liability company (coöperatieve vennootschap met beperkte aansprakelijkheid – cvba or société cooperative à responsabilité limitée – SCRL) are among the corporate forms that have been abolished, having now been restyled as private company (besloten vennootschap - bv or société à responsabilité limitée - SRL) and cooperative company (coöperatieve vennootschap - cv or société coopérative - SC), respectively. The holder of a marketing authorisation (MA) for a medicinal product is stated inter alia in the medicine’s product information. This means that MA holders are now required to amend their documents. The holders of other authorisations and registrations are required to do the same.

How to amend your MA documents
The new corporate form will have no impact on the content of your MA dossier. To amend your document, simply do the following:

  • Provide information on the new corporate form as an editorial change, in the context of a planned Type IB or Type II variation, under Chapter C of the Commission Classification Guideline. This is only possible as part of a variation that also amends product information.
  • Clearly state your new corporate form and the “editorial change” message in the application form as part of your variation, as well as in the “present and proposed” section.
  • You can find more information about an editorial change in the  CMDh/v’s Q&A for the Submission of Variations, question 3.16.
  • You can already include your new corporate form in your product information if you submit the amendment by 1 January 2024.

Please note, however, that you are not required to state your corporate form in the product information. If your corporate form is currently stated in your product information but you no longer wish that to be the case, you will have to submit the amendment.

If you amend the form of any companies not included in your product information, such as the distributor’s, you will not have to submit the amendment.

If you fail to replace your ‘bvba/SPRL’ status with ‘bv/SRL’ (or your ‘cvba/SCRL’ status with ‘cv/SC’), yet your company takes on a different form, you have to request that your authorisation be transferred.

How to amend documents relating to other authorisations or registrations with FAMHP
The new Company Code does not affect the validity of other authorisations or registrations, such as activity licences, import and export licences, or registrations as an economic operator. To communicate the new form of your company to us, please inform us when your authorisation comes up for periodic renewal:

  • Your correct corporate form must be stated on your authorisation by 1 January 2024 at the latest. That is also the last date upon which you may submit any amendments to your articles of association. 
  • If you need an amended authorisation, i.e. one that states your correct articles of associations, please request one by writing to the ordinary contact address for your type of authorisation.
  • The validity period of your authorisation will remain the same. It will not be extended as in the case of a renewal.
Last updated on
05/07/2019